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Do case reports involving people with medical ailments require ethical approvals? If they do not, then why?

I am located in Sweden, but am (almost) equally interested in conditions elsewhere.

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    As far as I know, any research, involving human subjects, requires approval by a corresponding ethical compliance body. The name of such body might differ from country to country, but usually it is called institutional review board (IRB), at least, in the United States. – Aleksandr Blekh Oct 11 '15 at 20:30
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    @AleksandrBlekh The tricky part is defining "research". Case reports - and studies intended for quality improvement (say, within a hospital) are often considered not research and don't need IRB approval. This gets especially tricky in research about hospital quality improvement :) – Fomite Oct 11 '15 at 23:20
  • @Fomite: Thank you for clarification. I already got that after reading the answers below :-). While I understand that such category is formally not considered as research, I think that still there should be some processes of clearing those studies with respect to ethical handling of patients and related data. Perhaps, it is part of standard healthcare guidelines and regulations (HIPAA, etc.). – Aleksandr Blekh Oct 11 '15 at 23:31
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    @AleksandrBlekh Yes, case reports must be HIPAA-compliant. – ff524 Oct 11 '15 at 23:35
  • What research have you done? Have you talked to your IRB or ethics board? Most of them will have many resources to help you figure this out. Have you talked to your advisor? What country are you in? We expect you to do some research before asking, and show us your research. A one-sentence question is a tip-off that you probably need to elaborate more on your specific situation and what research you've done. – D.W. Oct 12 '15 at 2:45
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From a legal point of view, in the United States, preparation of a case report for publication does not require review by the ethics board because case reports do not meet the legal definition of "research" (according to most interpretations):

Case reports submitted for publication do not strictly meet the criteria of research. Although a case report (defined as a retrospective analysis of one (1), two (2), or three (3) clinical cases) may be illustrative, it does not meet the Federal Policy for the Protection of Human Subjects definition of Research, which requires an investigation that contributes to generalizable knowledge about a disease or condition. Instead, a case report is intended to develop information to be shared for medical or educational purposes.

(Source: Tufts)

Many institutions therefore do not require any kind of review for publishing case reports. For example:

Q: Do faculty who prepare a case report as an article for submission to a journal require IRB approval prior to preparation?

No. A case report is a medical/educational activity that does not meet the DHHS definition of “research”, which is: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Therefore, the activity does not have to be reviewed by a JHM IRB.

(Source: John Hopkins Medicine)

(Another example: University of Wisconsin - Madison)

(Another example: Columbia)

As pointed out by Fomite, some institutions have an IRB make the determination that a study is "not human subjects research" even for a case study. For example:

A number of studies submitted to the UNC-Chapel Hill IRB are deemed “not human subjects” research which means, once reviewed and so designated, no further involvement with the IRB is needed unless a change in the study might alter that decision. This designation can be given to studies that involve human beings but are not considered to be research in the federal regulations (e.g., not systematic, as in single subject case studies and/or are not designed to contribute to generalizeable knowledge, as in program evaluation or quality improvement projects) or when information is collected from humans but is not about them (e.g, a survey of public health department directors about the content of programs offered). When a student has a study that might qualify for a “not human subjects research” designation from the IRB, the online IRB application will be shortened considerably. Once submitted, the IRB will review the application and let the student know if it agrees with the “not human subjects research” determination. If it does not agree, then a longer IRB application will be necessary.

(Source: UNC Nursing)

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    I would note that, at many institutions, it is up to the IRB, not the investigator, to determine this. For example, in parts of the UNC system, one must ask the IRB for a determination, even if you know beforehand that the answer is "No, this doesn't need approval." – Fomite Oct 11 '15 at 23:18
  • @Fomite Interesting. I initially thought you were referring to research that is classified as "exempt" under federal law. I'd never heard of that kind of thing for any other kind of research. Then I looked up these UNC guidelines and found that they do, indeed, require the IRB to make the determination that a study is "not human subjects research." Thanks! – ff524 Oct 11 '15 at 23:27
  • Yep. "Exempt" is a decision they make, not you. It is sometimes extremely silly (I had to submit a determination for a simulation-based study...) – Fomite Oct 11 '15 at 23:30
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    @Fomite Well, to be clear, all IRBs require that they themselves make the designation that a study is "exempt" (when it meets certain requirements for exempt status), I've never seen another IRB besides UNC's that requires they make the designation that a study is "not human subjects research" (as in a case study). My own IRB does not require that, and the others I linked above also do not require that. – ff524 Oct 11 '15 at 23:32
  • I understand you now. – Fomite Oct 11 '15 at 23:38
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In the US, under the common rule, the answer is generally no, because reporting on the cases of patients who were treated in the ordinary way doesn't constitute "research" in the sense defined by the common rule as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

However, if the case report involves several patients, this could at some point cross the line over into research. A widely used rule is that case reports involving 3 or fewer patients are exempt. If you're considering writing a case report you should check with your institution's IRB about specific policy at your institution. You will most likely want/need to get a document from your IRB stating that the case report is exempt.

Buyer beware, Your Mileage May Vary, etc. I'm a member of the IRB at an institution that doesn't have a medical school so we don't handle case reports.

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